WebHeart Platform

WebHeart is a proprietary, web-based, validated, 21 CFR part 11 compliant and configurable platform for the management, processing, analysis and reporting of cardiovascular safety and efficacy data including ECG and hemodynamic endpoints. Access to cardiac safety data in real time via WebHeart enables rapid and informed decision making for your clinical trial.

Benefits of conducting your study within the WebHeart platform include:

Compatibility with all ECG and ABPM technologies and operating systems

Centralized storage of cardiovascular data from both single center early phase trials to multicenter global studies

Role-based, 'rights-restricted' security model

Regulatory submission-ready ECG data

No special software, plug-ins, or add-ons required

Data Integrity and Security

WebHeart and associated processes have been developed and are continually enhanced to provide our sponsors with credible trial data that has been evaluated and managed within rigorous quality systems. WebHeart is 21CFR part 11 compliant and has successfully completed multiple external system audits. Disaster recovery and other data security considerations are built in to the platform and our SOPs.

Study Management

Throughout the course of a study, the BioClinica study team uses WebHeart as the foundation for study tracking and reporting. All study related items (e.g. calls, open DCFs, closed DCFs, site trainings, site shipments, regulatory documents, etc.) are tracked in WebHeart® and can be continually exported for submission to the project team.

The WebHeart® system provides the following Study Management benefits: